ec rep certificate · 2020-05-21 · cmc medical devices & drugs sl. ec rep certificate annex i...

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EC REP CERTIFICATE www.cmcmedicaldevices.com CMC MEDICAL DEVICES & DRUGS SL NO. CMC/CE/2020/01042020.1 CONFIRMED THAT CMC MEDICAL DEVICES & DRUGS S.L. Is the European Authorized Representative of GUANGDONG RUIYANG PHARMACEUTICAL CO.,LTD. Economic Corridor Development Zone,Lianjiang City,Guangdong Province,China The certificate remains valid until the expiration agreement of EC REP, manufacturing conditions, the quality system or relevant legislation are changed. The validity is conditioned by positive results of periodic surveillance audits. The product liability rests with the manufacturer in accordance with applicable directive and standard, after fulfilling of the relevant EU legislation requirements, the manufacturer shall affix relevant CE marking to all above mentioned models of the medical device. Complies with the applicable essential requirements of the council directive 93/42/EEC on medical devices as amended. The products in Annex I was registered in Spanish MOH with number RPS/406/2020 Issued on: 01/04/2020 Valid until: 31/03/2021 Authorized Signatory CMC Medical Devices & Drugs SL

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Page 1: EC REP CERTIFICATE · 2020-05-21 · CMC Medical Devices & Drugs SL. EC REP CERTIFICATE ANNEX I Medical Device Products Disposable Medical Face Mask. Title: Microsoft Word - Cert_ECREP_RUIYANG.docx

ECREPCERTIFICATE

www.cmcmedicaldevices.com

CMCMEDICALDEVICES&DRUGSSLNO.CMC/CE/2020/01042020.1

CONFIRMEDTHATCMCMEDICALDEVICES&DRUGSS.L.IstheEuropeanAuthorizedRepresentativeof

GUANGDONGRUIYANGPHARMACEUTICALCO.,LTD.�

EconomicCorridorDevelopmentZone,LianjiangCity,GuangdongProvince,China�

ThecertificateremainsvaliduntiltheexpirationagreementofECREP,manufacturingconditions,thequalitysystemorrelevantlegislationarechanged.Thevalidityisconditionedbypositiveresultsofperiodicsurveillanceaudits.Theproductliabilityrestswiththemanufacturerinaccordancewithapplicabledirectiveandstandard,afterfulfillingoftherelevantEUlegislationrequirements,themanufacturershallaffixrelevantCEmarkingtoallabovementionedmodelsofthemedicaldevice.Complieswiththeapplicableessentialrequirementsofthecouncildirective93/42/EEConmedicaldevicesasamended.TheproductsinAnnexIwasregisteredinSpanishMOHwithnumberRPS/406/2020Issuedon:01/04/2020 Validuntil:31/03/2021

AuthorizedSignatoryCMCMedicalDevices&DrugsSL

Page 2: EC REP CERTIFICATE · 2020-05-21 · CMC Medical Devices & Drugs SL. EC REP CERTIFICATE ANNEX I Medical Device Products Disposable Medical Face Mask. Title: Microsoft Word - Cert_ECREP_RUIYANG.docx

ECREPCERTIFICATE

www.cmcmedicaldevices.com

ANNEXIMedicalDeviceProducts

DisposableMedicalFaceMask

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